A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
This open-label single arm study will assess the efficacy, safety and tolerability of
Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive
oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until
disease progression or withdrawal from study and will be assessed at regular intervals for
tumour response and tolerability. Target sample size is <100 patients.
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
This randomized, open-label study evaluated the efficacy, safety and tolerability of
vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with
metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally
twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was
continued until disease progression or unacceptable toxicity occurred. The data and safety
monitoring board recommended that patients in the dacarbazine group be allowed to cross over
to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as
both overall survival and progression-free survival endpoints had met the prespecified
criteria for statistical significance in favor of vemurafenib.
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
Active, not recruiting
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will
evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600
mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E
mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have
progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are
eligible. Participants will be assigned to different cohorts with escalating oral doses of
vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage
[DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until
disease progression, unacceptable toxicity or any other discontinuation criterion is met.
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